VITROS 6802413Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10758750002740), received between Nov 15, 2022 and Sep 30, 2026 — classified as 1 injury, 68 malfunctions.

The most frequently reported specific device problem is “High Test Results” (38 reports).

12 FDA recall records name this device's identifier, 7 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 9, 2025Open, Classified

   A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

   Z-2038-2025 · Root cause: Software design · FDA record ↗

2. Dec 19, 2024Open, Classified

   The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

   Z-1005-2025 · Root cause: Software Design Change · FDA record ↗

3. Jan 26, 2024Open, Classified

   A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

   Z-1231-2024 · Root cause: Software Design Change · FDA record ↗

4. Jan 26, 2024Open, Classified

   A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

   Z-1226-2024 · Root cause: Software Design Change · FDA record ↗

5. Jan 22, 2024Open, Classified

   Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

   Z-1221-2024 · Root cause: Component change control · FDA record ↗

6. Oct 10, 2023Open, Classified

   During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

   Z-0545-2024 · Root cause: Under Investigation by firm · FDA record ↗

7. Mar 10, 2023Open, Classified

   MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

   Z-1556-2023 · Root cause: Under Investigation by firm · FDA record ↗

8. Jul 8, 2019Terminated

   Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

   Z-2179-2019 · Root cause: Software design · FDA record ↗

9. Feb 20, 2019Terminated

   Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems

   Z-1287-2019 · Root cause: Software design · FDA record ↗

10. Oct 19, 2018Terminated

    Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

    Z-0650-2019 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

11. Apr 6, 2016Terminated

    Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

    Z-1914-2016 · Root cause: Software design · FDA record ↗

12. Apr 6, 2015Terminated

    Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.

    Z-1743-2015 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951324 ↗
• MalfunctionSep 10, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716032 ↗
• MalfunctionJun 15, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED DIGOXIN (DGXN) RESULTS OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1939-0277-3072 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 VITROS DGXN RESULT OF 1.74 NMOL/L VS THE EXPECTED RESULT OF < 0.51 NMOL/L PATIENT 2 VITROS DGXN RESULT OF 2.04 NMOL/L VS THE EXPECTED RESULT OF 0.57 NMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS DGXN RESULTS WERE OBTAINED WHILE PROCESSING PATIENT SAMPLES. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501046 ↗
• MalfunctionMay 28, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED WHEN NON-VITROS QCS WERE PROCESSED USING VITROS NBNP2 AND VITROS CKMB2 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS NBNP2, MAS LEVEL 1 (LOT 27041) RESULTS OF 128.88, 219.67, 236.09, 219.13, 207.59, 175.37, 170.78 AND 180.57 PG/ML VERSUS THE BASELINE MEAN RESULT OF 335.5 PG/ML VITROS NBNP2, MAS LEVEL 3 (LOT 27043) RESULT OF 5863.69 PG/ML VERSUS THE BASELINE MEAN RESULT OF 7472.0 PG/ML VITROS CKMB2, MAS LEVEL 1 (LOT 27041) RESULTS OF 1.16, 2.37, 2.16, 2.15, 2.08, 1.88, 1.52 AND 1.23 NG/ML VERSUS THE BASELINE MEAN RESULT OF 3.67 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315815 ↗
• MalfunctionMay 26, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD ETHANOL/AMMONIA CONTROLS, LOT 54480 USING VITROS AMON SLIDE LOT 1023-0271-2293 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD L2 VITROS AMON RESULTS OF 120.5 AND 109.6 UMOL/L VS. THE EXPECTED RESULT OF 90.91 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE NON-REPRODUCIBLE VITROS AMON RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID AND THERE WAS NO ALLEGATION OF PATIENT HARM. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284283 ↗
• MalfunctionMay 18, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED HBA1C RESULTS WERE OBTAINED FROM A VITROS %A1C PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS HBA1C REAGENT LOT: 1539-48-3598 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS %A1C PV II LOT: A2602 RESULTS OF 9.38, 9.29, 9.40, 9.26 AND 9.44 %A1C VS AN EXPECTED RESULT OF 10.63 %A1C BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED RESULTS WERE OBTAINED FROM A CONTROL FLUID AND WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES HAD BEEN AFFECTED OR QUESTIONED. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209737 ↗
• MalfunctionApr 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT THE SAMPLE ID (SID) FOR TWO DIFFERENT PATIENT SAMPLES WERE MIS-ASSOCIATED WITH THE INCORRECT PATIENTS NAME AND RESULTS WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THIS EVENT MEETS THE CRITERIA FOR A REPORTABLE EVENT, AS TEST RESULTS COULD HAVE BEEN MISREPORTED OUT OF THE LABORATORY LEADING TO INAPPROPRIATE INTERVENTION WITH THE POTENTIAL FOR SERIOUS INJURY TO THE PATIENT. THE CUSTOMER IDENTIFIED THE DISCREPANCY, AND NO MIS-ASSOCIATED PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971021 ↗
• MalfunctionApr 16, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS HBA1C REAGENT LOT 1539-45-3183 RESULTS WERE OBTAINED FROM AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SAMPLES AND A LEVEL 2 VITROS %A1C PERFORMANCE VERIFIER (PV) FLUID ON A VITROS 5600 INTEGRATED SYSTEM. API SAMPLE GLY02 VITROS HBA1C RESULTS OF 7.9, 8.23, 8.07, 8.28 %A1C VS THE EXPECTED RESULT OF 9.6 %A1C API SAMPLE GLY03 VITROS HBA1C RESULTS OF 7.1, 7.31, 7.28 %A1C VS THE EXPECTED RESULT OF 8.35 %A1C VITROS %A1C PV II, LOT X2393 VITROS HBA1C RESULTS OF 7.99, 8.04, 8.08, 8.04, 8.11, 7.91, 8.14, 8.08, 8.13, 8.09, 8.18 % A1C VS. THE BASELINE MEAN OF 9.16 %A1C. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS HBA1C RESULTS WERE OBTAINED FROM NON-PATIENT PROFICIENCY AND QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904034 ↗
• MalfunctionApr 8, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED HSTNI RESULTS OBTAINED WHEN THE CUSTOMER WAS PROCESSING VITROS HSTNI LOW CONTROLS (LOT 0350) USING VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I (HSTNI) REAGENT PACK LOT 1510 ON A VITROS 5600 INTEGRATED SYSTEM. RESULTS OF 29.34, 28.44 AND 29.09 NG/L VERSUS THE PACKAGE INSERT MEAN VALUE OF 9.39 NG/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER-THAN-EXPECTED VITROS HSTNI RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. HOWEVER, THE INVESTIGATION CANNOT RULE OUT THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER 1(B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820679 ↗
• MalfunctionMar 25, 2026Incorrect Measurement

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A SAMPLE METERING EVENT OCCURRED WHERE SAMPLE FLUID WAS ASPIRATED FROM THE WRONG TUBE/CUP POSITION OF A SAMPLE TRAY FOR THREE DIFFERENT PATIENT SAMPLES WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MIS-ASSOCIATED PATIENT RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE MIS-ASSOCIATED PATIENT SAMPLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689643 ↗
• MalfunctionFeb 11, 2026False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, REACTIVE VITROS SYPHILIS (SYPH) RESULTS WERE OBTAINED FROM THREE SAMPLES FROM A SINGLE PATIENT WHEN PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS SYPH TPA REAGENT LOTS 1760 AND 1790 ON A VITROS 5600 INTEGRATED SYSTEM - REFURBISHED. THE RESULTS WERE DISCORDANT WHEN COMPARED TO THE RESULTS FROM THE SECOND SAMPLE FOR THE PATIENT PROCESSED USING AN ALTERNATE VITROS 5600 SYSTEM AT THE SITE AS WELL AS A NEGATIVE RAPID PLASMA REAGIN (RPR) RESULT FOR THE PATIENT. VITROS SYPH LOT 1760 PATIENT 1 SAMPLE 1 RESULTS OF 1.48 AND 1.61 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF 0.57 S/C (NON-REACTIVE) PATIENT 1 SAMPLE 2 RESULTS OF 1.66, 1.75, 1.75, 1.32, 1.57, 1.70 AND 1.76 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF 0.57 S/C (NON-REACTIVE) VITROS SYPH LOT 1790 PATIENT 1 SAMPLE 3 RESULTS OF 1.69, 1.96 AND 1.99 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF 0.57 S/C (NON-REACTIVE) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, FALSE REACTIVE VITROS SYPH DONOR SAMPLE RESULTS WERE NOT R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316976 ↗
• MalfunctionJan 6, 2026Use of Device Problem

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT RESULTS FROM SIX DIFFERENT PATIENT SAMPLES WERE ASSOCIATED WITH THE WRONG PATIENT SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE INITIAL RESULTS FROM THE AFFECTED SAMPLE TRAY WERE RELEASED FROM THE LABORATORY AND QUESTIONED BY PHYSICIANS AS THE RESULTS DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENTS. THE REPEAT RESULTS OF EACH PATIENT SAMPLE WERE BELIEVED TO BE THE TRUE RESULTS FOR EACH PATIENT. CORRECTED REPORTS WERE ISSUED FOR EACH PATIENT. NO TREATMENT WAS STARTED, STOPPED, OR ALTERED IN ANY WAY DUE TO THIS EVENT. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977801 ↗
• MalfunctionDec 5, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TROPONIN I (HSTNI) AND NT-PROBNP II (NBNP2) RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL (QC) AND PATIENT SAMPLES TESTED USING VITROS HSTNI REAGENT LOT 1340 AND VITROS NBNP2 LOT 2080 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS HSTNI: PATIENT 4 VITROS HSTNI RESULT OF 10.62 NG/L (BELOW AMI CUTOFF) VERSUS THE EXPECTED VITROS HSTNI RESULT OF 31.81 NG/L (ABOVE AMI CUTOFF) PATIENT 5 VITROS HSTNI RESULT OF 6.8 NG/L (BELOW AMI CUTOFF) VERSUS THE EXPECTED VITROS HSTNI RESULT OF 20.17 NG/L (ABOVE AMI CUTOFF) VITROS NBNP2: PATIENT 8 VITROS NBNP2 RESULT OF 924.0 PMOL/L VERSUS THE EXPECTED VITROS NBNP2 RESULT OF 2540.0 PMOL/L PATIENT 9 VITROS NBNP2 RESULT OF 937.0 PMOL/L VERSUS THE EXPECTED VITROS NBNP2 RESULT OF 2550.0 PMOL/L PATIENT 10 VITROS NBNP2 RESULT OF 745.0 PMOL/L VERSUS THE EXPECTED VITROS NBNP2 RESULT OF 2000.0 PMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS HSTNI AND VITROS NBNP2 RESULTS WERE REPORTED FROM THE LABORATORY AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727793 ↗
• MalfunctionNov 20, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT QUALITY CONTROL RESULTS SHIFTED LOW ON A SINGLE LEVEL OF NON-VITROS BIORAD CONTROL USING MULTIPLE VITROS MICROWELL ASSAYS ON A VITROS 5600 INTEGRATED SYSTEM. ALTHOUGH MULTIPLE MICROWELL ASSAYS WERE AFFECTED, ONLY RESULTS OBTAINED FROM THE VITROS CKMB AND NBNP2 ASSAYS MET POTENTIAL HEALTH AND SAFETY CRITERIA. VITROS CKMB ASSAY, REAGENT LOT: 3910 NON-VITROS BIORAD CONTROL LOT: 1003100 LEVEL 1 RESULT OF 3.24 NG/ML VS. THE EXPECTED RESULT OF 8.50 NG/ML VITROS NBNP2 ASSAY, LOT: 2150 NON-VITROS BIORAD CONTROL LOT: 1003100 LEVEL 1 RESULT OF 37.85 PG/ML VS. THE EXPECTED RESULT OF 150.2 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED CKMB AND NBNP2 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. PATIENT SAMPLES WERE NOT AFFECTED AND THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607981 ↗
• MalfunctionNov 20, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID (LOT 89760) USING VITROS NA+ SLIDE LOT 4275-1156-1471 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 2 (LOT 89760) VITROS NA+ RESULTS OF 135.5 AND 139.7 MMOL/L VERSUS THE EXPECTED RESULT OF 127.5 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED WHEN PROCESSING A NON-PATIENT CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER CLAIMED THAT PATIENT RESULTS WERE NOT IMPACTED BY THIS ISSUE. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606863 ↗
• MalfunctionNov 17, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED, VITROS TROPI ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULT OF 0.02 NG/ML VERSUS THE EXPECTED RESULT OF 0.057 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, LOWER THAN EXPECTED, VITROS TROPI ES RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575959 ↗
• MalfunctionAug 20, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF A NON-VITROS THERMOFISHER MAS CONTROL (LOT OCR2608) USING VITROS K+ SLIDE LOT 4102-1163-9277 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS K+ SLIDE LOT 4102-1163-9277 MAS OCR2608 L1 RESULTS OF 3.73, 3.82, 3.78, 3.81, 3.89, 3.72, AND 3.69 MMOL/L VS. THE EXPECTED RESULT OF 2.65 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854167 ↗
• MalfunctionJul 30, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED AMON RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS PROCESSED USING VITROS AMON SLIDE LOT 1020-0267-1182 ON A VITROS 5600 INTEGRATED SYSTEM. AMON L2 M2779 = 158.9, 143.1, 143.8, 150.3 VERSUS EXPECTED 199.7 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER REPORTED THAT THIS AMON ISSUE WAS ONLY WITH QUALITY CONTROL RESULTS. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664537 ↗
• MalfunctionJun 24, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4264-1144-6695 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF >250 MMOL/L VS AN EXPECTED RESULT OF 126.8 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED PATIENT SAMPLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 611147.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320281 ↗
• MalfunctionApr 21, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  AN ORTHO FIELD APPLICATION SPECIALIST CONTACTED ORTHO ON BEHALF OF A CUSTOMER TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I ES (TROPIES) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONINIES REAGENT LOT 5810 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 5.170 NG/ML VS. THE EXPECTED RESULT OF <0.012 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPIES RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877476 ↗
• MalfunctionApr 3, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED CARBAMAZEPINE (CRBM) AND LOWER AND HIGHER PHENYTOIN (PHYT) RESULTS WERE OBTAINED WHILE PROCESSING NON-VITROS THERMOFISHER MAS OMNICORE (OCR) QUALITY CONTROL (QC) FLUIDS USING VITROS CRBM CHEMISTRY PRODUCTS SLIDES AND VITROS PHYT CHEMISTRY PRODUCTS SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. VITROS CRBM: MAS OCR (LEVEL 2) CRBM RESULT OF <3.0 UG/ML VERSUS THE EXPECTED RESULT OF 10.65 UG/ML VITROS PHYT: MAS OCR (LEVEL 1) PHYT RESULTS OF <3.0 AND <3.0 UG/ML VERSUS THE EXPECTED RESULT OF 5.4 UG/ML MAS OCR (LEVEL 2) PHYT RESULTS OF 6.5 AND 6.1 UG/ML VERSUS THE EXPECTED RESULT OF 14.2 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND WERE NOT REPORTED FROM THE LABORATORY. IT IS UNKNOWN IF PATIENT SAMPLES HAVE BEEN IMPACTED BY THIS ISSUE. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761927 ↗
• MalfunctionApr 3, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF VITROS LIQUID PERFORMANCE VERIFIER (LPV) FLUIDS USING VITROS AMON SLIDE LOT 1020-0267-8941 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS LPV I LOT J2575 RESULTS OF 190.1, 169.5, 111.0 AND 188.4 UMOL/L VS. THE EXPECTED RESULT OF 47.5 UMOL/L VITROS LPV II LOT K2576 RESULTS OF 144.5, 135.9, 148.0, 249.9, 272.7, 159.6 AND 150.4 UMOL/L VS. THE EXPECTED RESULT OF 200.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT OF AFFECTED PATIENT RESULTS AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761160 ↗
• MalfunctionMar 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) WAS NOTIFIED BY AN ORTHO FIELD APPLICATION SPECIALIST TO REPORT THAT THE INCORRECT PATIENT'S NAME AND DATE OF BIRTH WERE ASSOCIATED WITH A PATIENT SAMPLE WHEN USING THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER IDENTIFIED THE DISCREPANCY, AND NO MIS-ASSOCIATED PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529368 ↗
• MalfunctionFeb 5, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CARBAMAZEPINE (CRBM) RESULTS WERE OBTAINED FROM TWO LEVELS OF VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL (QC) MATERIAL USING VITROS CHEMISTRY PRODUCTS CRBM SLIDES LOT 3916-0125-4879 ON A VITROS XT 7600 INTEGRATED SYSTEM. EVENTS OBSERVED ON 19 DECEMBER 2024 AND 20 DECEMBER 2024: VITROS TDM PVI (LOT C2150) CRBM RESULT OF 9.20 AND 8.76 UG/ML VERSUS THE CUSTOMER'S BASELINE MEAN VALUE OF 4.83 UG/ML VITROS TDM PVIII (LOT E2152) CRBM RESULT OF 20.00 UG/ML VERSUS THE CUSTOMER'S BASELINE MEAN VALUE OF 14.89 UG/ML EVENTS OBSERVED ON 28 JANUARY 2025: VITROS TDM PVI (LOT C2150) CRBM RESULT OF 9.74 UG/ML VERSUS THE CUSTOMER'S BASELINE MEAN VALUE OF 4.83 UG/ML VITROS TDM PVIII (LOT E2152) CRBM RESULT OF 19.55 UG/ML VERSUS THE CUSTOMER'S BASELINE MEAN VALUE OF 14.89 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS CRBM RESULTS WERE OBTAINED WHEN PROCESSING A NON-PATIENT QUALITY CONTROL FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317528 ↗
• MalfunctionFeb 4, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT: 4267-1147-8163 AND LOT: 4254-1134-2446 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS NA+ LOT: 4267-1147-8163: VITROS PV I LOT: V1665 RESULTS OF 152.2, 148.3, 145.5, 140.6, >250.0, >250.0, >250.0, 201.4, 200.0, 199.7, 198.8, 198.5, 198.3, 197.6, 197.2, 197.0, 196.0, 194.7, 193.9, 140.1, 140.0, 139.8, 139.5, 139.5, 138.8, 138.6, 138.5, 138.1, 137.3 AND 137.0 MMOL/L VS AN EXPECTED RESULT OF 115.4 MMOL/L VITROS NA+ LOT: 4254-1134-2446: VITROS PV I LOT: V1665 RESULT OF 138.9 MMOL/L VS AN EXPECTED RESULT OF 115.4 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309110 ↗